Aqilion has strengthened its pipeline with an innovative development program in the field of chronic inflammation.
With this acquisition, Aqilion is taking over all rights to the program, now under the name Regulus, from LEO Pharma. The project is ready for clinical trials and Aqilion plans to begin clinical development in 2022.
Aqilion will make an upfront payment that is a combination of cash and equity
Aqilion has acquired all rights to Regulus from LEO Pharma, which developed the project from early internal discovery research. Under the terms of the agreement, Aqilion will make an upfront payment that is a combination of cash and equity and LEO Pharma will become a shareholder of Aqilion. Furthermore, Aqilion will make additional payments from either product sales or through out-licensing revenues.
“We are always excited to see our R&D operations bring forward new compounds that have the potential to help patients in any indication. In this case EoE where Aqilion is the right partner to pursue the potential of LEO 142397 – now Regulus. LEO Pharma will continue our dedication to bringing forward new innovative treatments that are either first or best in class and changing the standards of care within medical dermatology,” says Thorsten Thormann, VP Research and Early Development in LEO Pharma.
Regulus is a novel next-generation selective JAK1 inhibitor previously developed as LEO 142397, now AQ280. Drugs with a similar mechanism of action have shown clinical efficacy in autoimmune and inflammatory diseases. Aqilion will initially investigate AQ280 as a potential therapy for eosinophilic esophagitis (EoE), an inflammatory disease of the esophagus. To date, no drugs with the same mechanism of action have been developed for EoE and there is a high unmet medical need, the company states. Aqilion will conduct the Regulus project in-house with the aim of starting a Phase 1 safety study in healthy volunteers in 2022, followed by a Phase 2a study in patients.
“It is both gratifying and inspiring for us at Aqilion to be able to expand our chronic inflammation pipeline with such an innovative, high quality and exciting program as Regulus. Expanding our pipeline with a project in early clinical development has been a priority and we now look forward to advancing Regulus, while benefiting from synergies with our pipeline of preclinical projects,” says Sarah Fredriksson, CEO of Aqilion.
Aqilion updates company pipeline
The company has also decided to expand the Alnitak program by investing resources in a project focused specifically on compounds with the potential to treat inflammatory conditions of the central nervous system (CNS). In order to prioritize projects in the company’s pipeline and to make best use of the company’s leading-edge expertise, Aqilion will simultaneously close the Alhena oncology project and focus exclusively on drug targets with great potential in inflammatory diseases, it states.
The goal of the Alnitak program is to develop an oral medication that specifically binds to and inhibits the TAK1 target protein. It has been shown that TAK1 (MAP3K7) acts as a master regulator of inflammatory signaling. Aqilion has identified highly potent TAK1 inhibitors through advanced structure-based molecular design. Public domain and internal data suggest that these compounds are among the most potent known TAK1 inhibitors that have drug-like properties. The Alnitak program will now be expanded with a project aimed at developing new compounds with properties suitable for the treatment of inflammatory conditions of the central nervous system.
To ensure that resources are prioritized for those projects deemed to have the greatest potential and to further focus the business on inflammatory diseases, Aqilion has decided to close Alhena, an early research project in oncology.
“I am proud that development in the Alnitak program has produced such good results and it is gratifying that the positive results have already received external recognition. There is a great need for novel treatments for inflammatory diseases, which has contributed to our strategic decision to ensure that we realize the potential of the Alnitak program within CNS as well. As a small biotech company that must prioritize our resources, it is a natural step to shut down the Alhena project, which we have not developed as far as the other projects, and which also falls outside our current primary focus area of inflammatory diseases,” says Sarah Fredriksson, CEO of Aqilion.